Hansa Biopharma announced that the Committee for Medicinal Products for Human Use (CHMP) of the European Medicines Agency (EMA) has adopted a positive opinion, recommending conditional approval of Idefirix (imlifidase) for the desensitization treatment of highly sensitized adult kidney transplant patients with a positive crossmatch against an available deceased donor. Endorsement of the positive opinion by the European Commission is expected in the third quarter of 2020.
In the US, following overall agreement with the FDA, Hansa Biopharma submitted a study protocol to the FDA on June 17, 2020. The randomized, controlled clinical study is planned to be initiated in Q4 this year and could support a future BLA submission in the US by 2023, as communicated earlier. The Company aims to recruit 45 highly sensitized patients at 10-15 centers in the US for this study.